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Open-label, Phase 0, dose-escalation study of 3 successive cohorts (3 subjects per cohort), to determine and characterize the plasma PK of gemcitabine HCl oral formulation (D07001-F4) administered once on Day 1 with 7 Days of study follow-up. In addition, oral tolerability and safety will also be assessed during this 1-week period.

Subjects will be treated with Gemcitabine HCl Oral Formulation according to assigned cohort (2 mg or 5 mg or 10 mg) on Day 1 of the 7-day study treatment period

Drug: Gemcitabine HCl Oral Formulation

Gemcitabine HCl Oral Formulation 80 mg/vial Subjects will be treated on Day 1 of the 7-day study treatment period

Other Name: D07001-F4

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male or female subjects aged 18 years and older.

Signed and dated informed consent form.

Subjects with malignancies with histological or pathologic confirmation and who are clinically stable.

History of treatment with at least 1 cytotoxic chemotherapy regimen for the current malignancy.

If the subject has received cytotoxic chemotherapy within the past 14 days, the subject is beyond the nadir of white blood cell and platelet counts.

At least 28 days have elapsed since the subject's prior radiotherapy or any major surgery (excluding diagnostic biopsy or venous access device placement).

If a women of child-bearing potential, subject has a negative pregnancy test and is not breast-feeding.

If a women of child-bearing potential, subject is using a medically acceptable form of birth control prior to screening and for the duration of their study participation and for 1 month after the end of the study.

Subject is willing to comply with protocol-required visit schedule and visit requirements and provide written informed consent.

Exclusion Criteria:

Subject has rapidly progressive disease or rapid clinical deterioration as assessed by the Investigator.

Subject is receiving full-dose (therapeutic) anticoagulation therapy.

Subject is receiving concomitant radiotherapy.

Subject is intolerant or allergic or has a known hypersensitivity to gemcitabine.